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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <lastUpdated>2026-07-20T08:28:06.598Z</lastUpdated>
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    <reference>APA1000-PT</reference>
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    <lastUpdated>2026-07-20T08:28:06.463Z</lastUpdated>
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    <tradeName>Sara Combilizer</tradeName>
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    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APA1000-SE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-20T08:28:06.447Z</lastUpdated>
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    <tradeName>Sara Combilizer</tradeName>
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    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>APA1000-TR</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-20T08:28:06.394Z</lastUpdated>
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    <tradeName>Sara Combilizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
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    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
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    <reference>APA1000-WW</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-20T08:28:06.368Z</lastUpdated>
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    <udiDi>D-590470340V2RSDEAH</udiDi>
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    <tradeName>Vitberg Recovery System - Aparat Bazowy RS2</tradeName>
    <deviceName>Vitberg Recovery System 2</deviceName>
    <manufacturerName>Vitberg Sikora Jacek</manufacturerName>
    <manufacturerSrn>PL-MF-000010936</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V2ABSP</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:04:22.908Z</lastUpdated>
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    <deviceName>C-Mill</deviceName>
    <manufacturerName>Motek Medical B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010803</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY012</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:40:14.390Z</lastUpdated>
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    <deviceName>Eccentron</deviceName>
    <manufacturerName>BTE Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000041076</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Eccentron LE1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:36:40.775Z</lastUpdated>
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    <deviceName>MCU - Multi Cervical Unit</deviceName>
    <manufacturerName>BTE Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000041076</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCU 2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:36:35.327Z</lastUpdated>
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    <basicUdiDi>08500010960112BA</basicUdiDi>
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    <deviceName>Therm-X Garment - Hand</deviceName>
    <manufacturerName>Zenith Technical Innovations, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000047832</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TX0112</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:04:33.763Z</lastUpdated>
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    <deviceName>Therm-X Garment Extender Straps</deviceName>
    <manufacturerName>Zenith Technical Innovations, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000047832</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TX0109</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:04:32.738Z</lastUpdated>
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    <udiDi>00850001096478</udiDi>
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    <deviceName>Therm-X Split Hose</deviceName>
    <manufacturerName>Zenith Technical Innovations, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000047832</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TX0208</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:04:31.931Z</lastUpdated>
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    <deviceName>Therm-X Garment - Half Leg</deviceName>
    <manufacturerName>Zenith Technical Innovations, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000047832</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TX0111</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:04:17.130Z</lastUpdated>
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    <deviceName>Therm-X Garment - XL Shoulder</deviceName>
    <manufacturerName>Zenith Technical Innovations, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000047832</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TX0110</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:04:15.899Z</lastUpdated>
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    <deviceName>Therm-X Garment - Hip</deviceName>
    <manufacturerName>Zenith Technical Innovations, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000047832</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TX0108</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:04:11.885Z</lastUpdated>
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    <deviceName>Therm-X Garment - Shoulder</deviceName>
    <manufacturerName>Zenith Technical Innovations, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000047832</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TX0101</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:04:11.081Z</lastUpdated>
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    <deviceName>Therm-X Garment - Elbow</deviceName>
    <manufacturerName>Zenith Technical Innovations, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000047832</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TX0103</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:04:10.284Z</lastUpdated>
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    <deviceName>Therm-X Garment - Ankle</deviceName>
    <manufacturerName>Zenith Technical Innovations, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000047832</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TX0104</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:04:09.462Z</lastUpdated>
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